Ventilation interface for sleep apnea therapy

• US 6,997,177 B2
• Filed: 07/13/2004
• Issued: 02/14/2006
• Est. Priority Date: 03/13/1999
• Status: Expired due to Term

• Current Assignee: Salter Labs, LLC
• Original Assignee: Innomed Technologies Incorporated (SunMed Group Holdings LLC)
• Inventors: Wood, Thomas J.
• Primary Examiner(s): MITCHELL, TEENA KAY
• Application Number:
  US10/889,324
• Publication Number:
  US 20050039757A1
• Time in Patent Office: 581 Days
• Field of Search: 128/200.24, 128/202.18, 128/203.22, 128/204.12, 128/205.24, 128/206.11, 128/206.12, 128/206.18, 128/206.21, 128/206.27, 128/206.28, 128/207.11, 128/207.13, 128/207.18, 128/203.19, 128/203.29, 128/205.25, 600/529, 600/532, 600/538
• US Class Current: 128/200.24
• CPC Class Codes: A61M 16/0616 with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/1045 Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
• CPC Class Codes: A61M 16/1055 bacterial
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2205/42 Reducing noise

Abstract

The ventilation interface for sleep apnea therapy interfaces a ventilation device to the patient'"'"'s airways. The ventilation interface includes a pair of nasal inserts made from flexible, resilient silicone which are oval shaped in cross-section and slightly tapered from a base proximal the ventilation supply to the distal tip end. A bead flange is disposed about the exterior of each insert at the distal end of the insert. In one embodiment, a valve is disposed between the nasal inserts and a source of positive airway pressure, the valve having a rim with a one-way diaphragm pivotally attached to the valve body with an inflatable bladder depending from the rim which seals against an exit port during inspiration and deflates to uncover the exit port on expiration. Another embodiment has nasal inserts without positive airway pressure but with a removable filter in the inserts for filtering inspired air.

Claims

1. A method of forming ventilation interface, comprising:

forming at least one nasal insert from a flexible, resilient, soft, biocompatible material, wherein each nasal insert comprises a hollow body, a base end configured to connect to a ventilator air flow and an open distal tip end, each nasal insert being substantially oval in cross-section at the base end and the distal end and continuously oval in cross-section between the base end and the distal end; and

forming a flange as a bead disposed about the distal tip end of each said nasal insert, the flange being configured to seal against a naris of a patient'"'"'s nose, wherein each said nasal insert is configured to be compressed and inserted into the patient'"'"'s naris to a patient'"'"'s mucosal membrane and being retained therein solely by said flange, by the resilience of said nasal insert, and by lateral pressure against the naris from ventilator air flow through each said nasal insert.

2. The method according to claim 1, further comprising:

making each said nasal insert from silicone.

3. The method according to claim 1, wherein each said nasal insert has an internal diameter of 0.75 inches on a major axis and 0.5 inches on a minor axis.

4. The method according to claim 1, wherein each said nasal insert has a wall thickness between about 1/32 and 1/20 inches.

5. The method according to claim 1, wherein each said nasal insert has a softness measuring between about 15 and 40 on a type A Shore durometer.

6. The method according to claim 1, further comprising:

forming a pair of valves, each valve including a hollow valve body defined by at least one sidewall and having a superior end and an inferior end, the base of each said nasal insert being attached to the superior end of one of said valve bodies, respectively, in order to form a continuous air conduit.

7. The method according to claim 6, further comprising:

providing a pair of supply tubes configured to deliver a gas from a ventilator, the inferior end of each of said valve bodies being connected to a separate one of the pair of supply tubes so that each said nasal insert is independently supplied with gas from the ventilator.

8. The method according to claim 6, wherein forming each valve further comprises:

providing an exit port in said at least one sidewall, tile exit port being formed by a mesh grid;

attaching a binge to said at least one sidewall opposite said exit port;

pivotally attaching a gate to said hinge, the gate having a rigid rim defining the perimeter of the gaze and a one-way, gas permeable diaphragm extending across the rim;

attaching a flexible, tubular bladder having a first end to the rim of said gate;

attaching an open second end to the side wall of said valve body;

wherein said gate pivots between a first position during inspiration in which the rim of said gate is above said exit port, said bladder inflating to form a seal over said exit port, and a second position during expiration in which the rim of said gate is below said exit port, opening maid exit port for release of exhaled air to the atmosphere.

9. The method according to claim 8, wherein said one-way diaphragm is configured to permit inflow of inspired air from the inferior end of said valve body through said diaphragm and the superior end of said valve body and wherein one-way diaphragm is configured to block outflow of exhaled air in a direction opposite to inflow.

10. The method according to claim 8, further comprising:

forming a stop extending from the sidewall of said valve body positioned above said exit port, wherein said stop is configured to limit travel of said gate during inspiration.

11. The method according to claim 8, further comprising:

forming a stop post extending from the sidewall of said valve body positioned below said exit port in order to limit travel of said gate during expiration.

12. A ventilation method comprising:

compressing at least one nasal insert, wherein said nasal insert comprises a hollow body, a base end configured to connect to a ventilator air flow and an open distal tip end, each nasal insert being substantially oval in cross-section at the base end and the distal end and continuously oval in cross-section between the base end and the distal end;

inserting said nasal insert into a patient'"'"'s nose;

sealing said nasal insert via a flange that is dispose about the distal end tip of said nasal insert, wherein said flange is formed as a bead disposed about the distal tip end of each said nasal insert; and

connecting the base end of the nasal insert to a ventilator air flow.

13. The method according to claim 12, further comprising:

retaining said nasal insert solely by said flange and by the resilience of said nasal insert.

14. The method according to claim 12, further comprising:

retaining said nasal insert by said flanges, by the resiliency of said nasal insert, and by lateral pressure of the air flow.

15. The method according to claim 14, wherein the lateral pressure is maintained at between five and fifteen centimeters of water.

16. The method of claim 12, further comprising:

delivering gas from a ventilator through a supply tube,

connecting an inferior end of a valve body to the supply tube so that each said nasal insert is independently supplied with gas from the ventilator, wherein each valve body is defined by at least one sidewall and has a superior end and an inferior end, the base of each said nasal insert being attached to the superior end of one of said valve bodies, respectively, in order to form a continuous air conduit;

pivoting a gate in said valve body to a first position during inspiration in which a rim of said gate is above an exit port and inflating a bladder to form a seal over said exit port; and

pivoting said gate to a second position during expiration in which the rim of said gate is below said exit port, thereby opening said exit port for release of exhaled air to the atmosphere.

17. The method of claim 16, further comprising:

permitting inflow of inspired air from the inferior end of said valve body through a one-way diaphragm and the superior end of said valve body; and

blocking outflow of exhaled air in a direction opposite to inflow.

18. The method of claim 16, further comprising:

limiting travel of said gate during inspiration with a stop extending from the sidewall of said valve body positioned above said exit port.

19. The method of claim 16, further comprising:

limiting travel of said gate during expiration with a stop post extending from the sidewall of said valve body positioned below said exit port.

20. A method of forming ventilation interface, comprising:

forming a nasal insert, as a hollow body made from a flexible, resilient, soft, biocompatible material, having a base end and a tip end, the nasal insert being substantially oval in cross-section at the base end and the tip end and continuously oval in cross-section between the base end and the tip end;

forming a bead disposed about the tip end of said nasal insert as a flange that is adapted to form a seal;

providing a one-way expiratory diaphragm disposed across the base end of said nasal insert, the expiratory diaphragm permitting passage of exhaled air from the tip end through the base end, but preventing passage of inhaled air through the base end towards the tip end;

providing a one-way inspiratory diaphragm disposed in said nasal insert adjacent the base end, the inspiratory diaphragm permitting passage of inhaled air from outside said nasal insert, through the inspiratory diaphragm, and into said nasal insert, but preventing passage of exhaled air through the inspiratory diaphragm and out of said nasal insert; and

placing a removable filter over said inspiratory diaphragm.

21. The method according to claim 20, wherein said filter is capable of filtering at least one irritant selected from the group consisting of dust, pollen, allergens and bacteria from inhaled air.

22. The method according to claim 20, wherein said retaining means comprises an elastic mesh disposed over said inspiratory diaphragm.